TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a mod

FDA device recall Z-3161-2011 · posted 2011-09-07 · Terminated

Recall details

Recalling firm

TiSport, Llc

Reason for recall

The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off.

Action taken

An Urgent Medical Device Correction letter, Product Correction Kit , and the Installation Instructions were sent to domestic suppliers, international suppliers, Veterans Administration hospitals and international distributors by US Priority Mail and by FedEx three days service. The letter identified the affected product and the reason for the recall. Customers were instructed not to send the product to their end user until the correction was made or to identify their end user and notify the end user of the product correction. Replacement parts and instructions to correct the issue were enclosed with the letter. Customers were to destroy the removed parts once they had completed the correction. Customers were to also return the Medical Device Correct Report that was provided, by fax to 509-586-2413, or email to ProdCorrection@tilite.com. Customers can call Technical Support at 800-545-2266, ext. 239 with any questions about recall.

Root cause

Component design/selection

Status

Terminated

Product code

IOR

Quantity affected

1,037 units

Distribution

Worldwide Distribution

Date initiated

2011-07-05

Date posted

2011-09-07

Date terminated

2012-07-27

Location

Pasco, WA

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